Search Results for “EC” – Page 290 – media

Sperogenix Therapeutics introduced for US$124 million! New drug for Duchenne muscular dystrophy planned to be included in priority review

Today (February 18), the official website of the Center for Drug Evaluation (CDE) of the NMPA of China announced that the vamorolone oral suspension applied by Sperogenix Therapeutics is scheduled to be included in the priority review, and the indication is Duchenne muscle aged 4 years and above. Public information shows that this is a new rare disease drug introduced by Sperogenix Therapeutics from Santhera Pharmaceuticals for US$124 million. It has been approved to treat DMD in the United States and the European Union. It is reported that vamorolone has achieved positive results in the key clinical study VISION-DMD and three open-label studies and expansion studies. In the VISION-DMD study, compared with placebo, the vamorolone group reached the primary endpoint after 24 weeks of treatment, and the difference in the time required from lying to standing was statistically significant compared with the placebo group. Additionally, male patients treated with vamorolone ...
- Source: drugdu
- 130
- February 22, 2024
ABPI publishes new prescribing support guide for healthcare professionals

The Association of the British Pharmaceutical Industry (ABPI) has published a new guide to how the pharmaceutical industry can support healthcare professionals (HCPs) with prescribing decisions. The report, No More, No Less: a Guide to the Appropriate Prescribing of Medicines and the Role of Industry, highlights the responsibilities that pharmaceutical companies have to ensure they provide accurate information to support high-quality healthcare. Every year in the UK, over one billion medicines are prescribed and dispensed from more than 18,000 preparations licenced for use by the Medicines and Healthcare products Regulatory Agency. The current resources available for pharmaceutical companies to support the quality, safety and efficacy of medicine include the Summary of Product Characteristics, medical information and pharmacovigilance expertise, as well as medical advisers. In the UK, most pharmaceutical companies provide a Medical Information Service (MIS) for HCPs, patients and the public via telephone or email. In addition, MIS personnel or ...
- Source: drugdu
- 97
- February 22, 2024
ASTRUM-004 Featured on the Cover of Cancer Cell

On February 12, 2024, the Volume. 42 Issue. 2 of Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3, was published online. ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was highlighted on the front cover of the issue. This marks the first time a clinical study of an innovative Chinese drug has been featured on the journal’s cover in its 22-year history. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. “Zhou et al. report the results of a phase 3 trial that demonstrates the efficacy and safety of serplulimab plus chemotherapy as first-line treatment for patients with advanced squamous non-small-cell lung cancer (sqNSCLC).” The editors highly commended ASTRUM-004 and the cover design. “The cover features a collage of pathology slices ...
- Source: drugdu
- 135
- February 22, 2024
Hengrui Medical made a new breakthrough in the field of medical nuclide preparation and successfully prepared 64Cu in batch.

Recently, Hengrui Medical ushered in a new breakthrough in the field of medical nuclide preparation, and its subsidiary Tianjin Hengrui Medical Co., Ltd. has realized the independent mass production of copper chloride [64Cu] solution with stable and controllable quality through independent projects and technological research, and the PET imaging of the labeled drug is good for small animals. This breakthrough of Hengrui Medicine lays the foundation for the development of 64Cu-labeled diagnostic drugs, and can also provide the industry with the nuclide for the R&D and production of such drugs. In 2021, eight national ministries and commissions jointly issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), which explicitly pointed out that 64Cu is an isotope with broad application prospects, and the key technology of gas pedal preparation of 64Cu is the key task of the plan. Radiopharmaceuticals refer to a special class of drugs containing radionuclides for ...
- Source: drugdu
- 130
- February 22, 2024
Gilead signs antibody deal with Biocytogen amid ADC buzz

Biocytogen Pharmaceuticals shared plans for its new antibody evaluation and option agreement with Gilead Sciences. In the deal, Gilead will gain access to Biocytogen’s fully human antibody library. The agreement gives Gilead a three-year nomination period to choose its targets of interest and assess the selected antibodies, with the option of acquiring selected antibodies for worldwide therapeutic development. Biocytogen owns four genetically engineered RenMice platforms for the discovery of multiple antibody types. This includes bispecific antibody-drug conjugates (ADC), TCR-mimic antibodies and more. As of June 2023, the China-based company was part of 50 therapeutic antibody and multiple clinical asset co-development, out-licensing and transfer agreements. Earlier this year, Biocytogen partnered with Radiance Biopharma to share its bispecific ADC expertise. The company also signed deals with Ona Therapeutics in December 2023 and Myricx Bio in September 2023 to develop ADCs. This correlates with an uptick in high-value deals recently seen in the ...
- Source: drugdu
- 82
- February 21, 2024
Yet another clinical hold for Gilead’s magrolimab trials

Gilead Sciences had paused enrolment in the magrolimab solid tumour trials, with the FDA requesting a partial clinical hold on these studies. Earlier this month, the US regulatory agency placed a full clinical hold on all the clinical trials of magrolimab for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). “Gilead will likely decide to deprioritise the magrolimab programme entirely,” said Sakis Paliouras, associate director for oncology research and analysis at GlobalData. Adding: “it is less likely, but still possible, that the company will come back from the clinical hold and continue the programme.” The latest partial clinical hold affects the Phase II trials of magrolimabin multiple solid tumour conditions such as head and neck squamous cell carcinoma (NCT04854499), triple-negative breast cancer (NCT04958785), and colorectal cancer (NCT05330429). In addition to Gilead-sponsored trials, the partial clinical also applies to Investigator Sponsored Studies with magrolimab in solid tumours. Paliouras said the blood ...
- Source: drugdu
- 153
- February 21, 2024
Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients

Davy James Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above. The FDA has approved an expanded indication for Novartis’ and Roche’s Xolair (omalizumab) as the first medication indicated to reduce allergic reactions from exposure to one or more food allergens in individuals over 1 year of age with immunoglobulin E (IgE)-mediated food allergy. Xolair is a monoclonal antibody that binds to and inhibits IgE, which is involved in the pathophysiology of the allergic inflammation characteristic of asthma. Through this mechanism of action, IgE down-regulates the immune response to help gain control over allergy-driven inflammation. “Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result. Today’s ...
- Source: drugdu
- 163
- February 20, 2024
Jacobio Announces China CDE Clearance for Phase III Clinical Trial of SHP2 Inhibitor Plus KRAS G12C Inhibitor

BEIJING and SHANGHAI and BOSTON, Feb. 18, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor glecirasib and novel SHP2 inhibitor JAB-3312. JAB-3312 is the first SHP2 inhibitor entered into phase III study globally in combination with KRAS G12C inhibitor. This approved study in China is a randomized active controlled phase III trial design to evaluate the efficacy and safety of JAB-3312 in combination with glecirasib for first-line non-small cell lung cancer patients with KRAS G12C mutations. The control arm is the current standard treatment for first-line non-small cell lung cancer, which is the combination therapy of PD-1 antibody and chemotherapy. Jacobio initiated clinical trials of SHP2 inhibitors in 2018. Data presented by Jacobio in an oral presentation at the 2023 European Society for ...
- Source: drugdu
- 93
- February 20, 2024
Xyphos and Kelonia link for immuno-oncology drug development

Astellas subsidiary Xyphos Biosciences has entered a research partnership and licence agreement with Kelonia Therapeutics aimed at developing new immuno-oncology therapeutics in an $875m deal. The alliance will merge Xyphos’ ACCEL technology with Kelonia’s in vivo gene placement system to develop universal, off-the-shelf in vivo chimeric antigen receptor (CAR) T-cell therapies for up to two programmes. Kelonia focuses on genetic medicine innovation and utilises its in vivo gene placement system to precisely deliver genetic material to the target cells within the patient’s body. This system employs lentiviral particles for efficient delivery. Xyphos’ ACCEL technology platform features the convertible CAR used on immune cells. Xyphos will oversee the development and marketing of the products resulting from the joint research. Kelonia is entitled to an upfront payment of $40m for the first programme. If Xyphos opts for the second programme, an additional $35m will be paid to Kelonia. The deal also includes ...
- Source: drugdu
- 107
- February 20, 2024
GSK concludes Aiolos Bio acquisition for $1.4bn

GSK has successfully concluded the acquisition of Aiolos Bio in a deal that could reach $1.4bn, marking a significant expansion of GSK’s respiratory biologics portfolio. The agreement, signed last month, includes an upfront payment of $1bn and $400m in regulatory milestone payments. The acquisition introduces AIO-001, a long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody, into GSK’s pipeline. The antibody is ready to enter Phase II clinical development. It targets adults with asthma and has the potential for extended dosing intervals, possibly every six months, due to its extended half-life and high potency. AIO-001 operates by attaching to the TSLP ligand, a key player in asthma inflammation, to hinder its signalling pathway. The acquisition significantly benefits the estimated 40% of severe asthma patients who suffer from low Type 2 (T2) inflammation. GSK’s commitment to respiratory diseases is further solidified with the addition of AIO-001, potentially redefining standard care for asthma patients. ...
- Source: drugdu
- 159
- February 20, 2024

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